Technical Operations Manager (Biologics – NPI)
Oversee a team of experts who conduct ground breaking science on a global scale every day. We are working with a client who are expanding their facility into a multi-million dollar state of the art biologics plant that will bring ground breaking scientific research to real life solutions for our patients.
They are putting in place a highly technical, progressive senior leadership team who will bring this expansion to reality.
As part of this project, we have been engaged to recruit a Technical Operations Manager who, reporting to the Site Director, will provide key strategic expertise and support to our manufacturing operations and new product introduction (NPI) activities.
This is an amazing opportunity for someone who is passionate about bringing R&D activities to commercial reality and who wants to grow their career locally and globally.
- Provide expertise and lead a highly technical team in all aspects of technical support for biologics manufacturing and NPI activities
- Identify and develop continuous improvement projects from a manufacturing process perspective while partnering closely with manufacturing operations, engineering and quality to deliver on these
- Prepare project budgets associated with future product introduction activities, including analytical equipment needs.
- Be responsible for scope identification and execution for NPIs.
- Plan and lead technical transfers for future product introductions.
- Work closely with R&D (Research & Development) and S&T (Science & Technology), on the process development of suitable future products.
Education & Experience:
- You will have a PhD in chemistry with 7 years OR MSc with 9 years OR BSc with 12+ years in biopharmaceutical processing, with relevant experience of process development, batch processing, technical transfers, commissioning and validation in the pharmaceutical industry
- A minimum of 7 years’ experience of start-ups and/or new product introductions to pharmaceutical facilities. Must be able to lead these activities in a start-up environment.
- 7 years of demonstrated process development skills, including the ability to deliver innovative manufacturing processes at industrial scale. Proven scale up skills, to facilitate the successful transition from laboratory to full scale production.
- Demonstrated strong leadership capability to coach and lead a team
- Ability to partner cross functionality in a matrix organisation both locally & globally
- Detailed knowledge of sterile manufacturing processes and operations
- Knowledge of antibody drug conjugates (ADCs)
- Detailed knowledge of cGMP and regulatory requirements relating to the pharmaceutical industry is required
For a confidential discussion and more information on the role, please contact Davin Ferguson on 0719140251 or email email@example.com
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